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732560

Hikma Pharmaceuticals USA, Inc. — FEI 2250102

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 30, 2011
Fiscal Year
2011
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Eatontown, NJ (United States)

Facility

Other inspections at this facility

  • 1079961 (NAI Fri Feb 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1054739 (NAI Fri Apr 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976090 (NAI Thu Jul 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942928 (NAI Thu Sep 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 864847 (VAI Wed Feb 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
144821 CFR 211.111Establishment of time limitations
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360221 CFR 211.160(a)Deviations from laboratory control requirements
434221 CFR 211.142(b)Storage under appropriate conditions
439121 CFR 211.180(e)(2)Items to cover on annual reviews
439921 CFR 211.186(b)(7)Theoretical yield statement including percentages